Global Regulatory Leader, CNS Submissions - Remote

Sumitomo Pharma; Lansing (MI); Remote; USD 196,000 - 245,000; Full time

Job summary

Sumitomo Pharma is seeking a highly experienced Regulatory Leader to drive global/regional regulatory strategies for CNS programs in the US. You will lead the Global Regulatory Team and coordinate cross‑functional efforts to ensure compliant submissions.

Primarily remote role with periodic on‑site meetings; expects leadership in Health Authority negotiations and post‑approval strategy. Requires a minimum of 10 years in biotech/pharma regulatory affairs and a Master’s degree in a scientific

Qualifications

• Bachelor's degree required; Master’s preferred in a scientific discipline.
• Minimum 10 years of regulatory experience in biotech/pharma.
• Experience leading global regulatory teams and submissions.

Responsibilities

• Lead the Global Regulatory Team (GRT) and regulatory activities aligned with product strategy.
• Plan and coordinate regulatory submissions and interactions with Health Authorities.
• Mentor junior staff and drive regulatory strategy for CNS programs.

Skills

Regulatory Affairs

Leadership

Regulatory Strategy

FDA Regulations

ICH Guidelines

Regulatory Submissions

Cross-functional Collaboration

Mentoring

Education

Bachelor's degree in a related field

Master's degree in a scientific discipline

Job description

Sumitomo Pharma is seeking a highly experienced Regulatory Leader to drive global/regional regulatory strategies for CNS programs in the US. You will lead the Global Regulatory Team and coordinate cross‑functional efforts to ensure compliant submissions.

Primarily remote role with periodic on‑site meetings; expects leadership in Health Authority negotiations and post‑approval strategy. Requires a minimum of 10 years in biotech/pharma regulatory affairs and a Master’s degree in a scientific